STAT+: Pharmalittle: We’re reading about a Vaxcyte pneumococcal shot, increasing pharma M&A, and more

This is STAT's Pharmalittle newsletter, a daily roundup of pharma news. The excerpt highlights two main items: Vaxcyte's Phase 3 win for its pneumococcal vaccine and an FDA review delay for Novo Nordisk's hemophilia A candidate. The title also references increasing pharma M&A, but the excerpt does not elaborate.

Vaxcyte disclosed that its experimental pneumococcal vaccine, VAX-31, hit the primary endpoints in a Phase 3 clinical trial, setting up competition with Pfizer and Merck. VAX-31 is designed to protect against 31 serotypes, or strains, of bacteria that can cause pneumococcal disease, including pneumonia, compared with 20 strains for Pfizer's Prevnar and 21 strains for Merck's Capvaxive. The company still needs results from two more trials before it can file for approval: a study of VAX-31 administered alongside an influenza vaccine and a study in adults who previously received a different pneumococcal shot.

Separately, the FDA extended its review of Novo Nordisk's experimental hemophilia A drug denecimig due to ongoing remediation work at a manufacturing facility. Novo submitted the application in September 2025 and had expected an FDA decision in the third quarter of 2026. The regulator has not set a new timeline. Novo said the FDA did not raise concerns about the drug's safety or effectiveness data, and the manufacturing site issues do not affect any of its other medicines currently on the market.